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Sign in to claim this brandBionet Co., Ltd.
South Korea·KR-MF-000013439
Last updated September 17, 2026
Information
- Country
- South Korea
- Address
- 61, Digital-ro 31-gil, Guro-gu, Seoul, South Korea
- Website
- ebionet.com
- —
- —
- [email protected]
- Phone
- +82-02-6292-6410
- PRRC Contact
- Sangwoo Lee
- EUDAMED SRN
- KR-MF-000013439
- FDA FEI Number
- 3003681187
- DUNS Number
- 689708212
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Electrocardiograph | many | EUDAMED | Class IIa | Active |
| Handheld Ultrasound Scanners | SonoMe/SONOFINDER | EUDAMED | Class IIa | Active |
| CardioExpress 5012 | many | EUDAMED | Class IIa | Active |
| Fc 1400 Fetal Monitor | K043598 | FDA 510(k) | Class II | Active |
| Cardio Xp | K102767 | FDA 510(k) | Class II | Active |
| Cardio10 | K220535 | FDA 510(k) | Class II | Active |
| Fc 700 Fetal Monitor | K043597 | FDA 510(k) | Class II | Active |
| Bionet Bm3plus Patient Monitor | K082008 | EUDAMEDFDA 510(k) | Class II | Active |
| Ekg-Plus Ii Software | K090895 | FDA 510(k) | N/A | Active |
| Cardio 7 | K113306 | FDA 510(k) | Class II | Active |
| SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) | K220169 | FDA 510(k) | Class II | Active |
| Cardio P1 | K231150 | FDA 510(k) | Class II | Active |
| Spm-300 | K130322 | FDA 510(k) | Class II | Active |
| CardioExpress 4012 | many | EUDAMED | Class IIa | Active |
| Cardio Q70 | many | EUDAMED | Class IIa | Active |
| Cardio Q50 | many | EUDAMED | Class IIa | Active |
Related Companies
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bionet Company, Ltd. US